Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-28 @ 8:21 AM
Study NCT ID:
NCT01945892
Status:
COMPLETED
Last Update Posted:
2013-09-19
First Post:
2013-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexamethasone-Implant for the Treatment of Macula Edema Due to Irvine Gass Syndrome
Sponsor:
Ludwig-Maximilians - University of Munich
Organization:
Study Overview
Official Title:
Ozurdex as an Treatment Option for Macula Edema Due to Irvine Gass Syndrome
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To analyze macula edema formation after cataract surgery called Irvine-Gass-Syndrome.
Detailed Description:
20 to 25 patients suffering from Irvine Gass Syndrom should be monitored for at least six months, controlled monthly. In all cases best corrected visual acuity, Spectralis-OCT (volume thickness scan), fundus photography (Optomap), intraocular pressure, slitlamp assessment and indirect ophthalmoscopy should be performed on every visit. Fluorescein angiography should be performed at baseline and after 3 and 6 months.
Inclusion criteria:
Patients older than 18 years who develop macula edema secondary to cataract surgery.
\- Consent agreement - Patients should be informed that it is possible to get an active medication (Ozurdex implant) as an "on label" indication from the health insurance company if the diagnosis is accepted as an intraocular inflammation form of "Uveitis posterior".
Exclusion criteria:
Visual acuity worse than 20/400, known history of glaucoma and steroid response, any macular disease interfering with visual acuity (DME, AMD, etc.), history of vitrectomy, use of systemic, periocular, or intraocular corticosteroids within 30 days.
Outcome:
* BCVA
* Patients suffering from diabetes mellitus should be evaluated also separately.
* Change in central retinal thickness using optical coherence tomography (OCT)
* Secondary parameters (elevated IOP, retinal detachments, vitreous hemorrhage, endophthalmitis rates)
Inclusion criteria:
Patients older than 18 years who develop macula edema secondary to cataract surgery.
\- Consent agreement - Patients should be informed that it is possible to get an active medication (Ozurdex implant) as an "on label" indication from the health insurance company if the diagnosis is accepted as an intraocular inflammation form of "Uveitis posterior".
Exclusion criteria:
Visual acuity worse than 20/400, known history of glaucoma and steroid response, any macular disease interfering with visual acuity (DME, AMD, etc.), history of vitrectomy, use of systemic, periocular, or intraocular corticosteroids within 30 days.
Outcome:
* BCVA
* Patients suffering from diabetes mellitus should be evaluated also separately.
* Change in central retinal thickness using optical coherence tomography (OCT)
* Secondary parameters (elevated IOP, retinal detachments, vitreous hemorrhage, endophthalmitis rates)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: